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Integrase Inhibitor
Long-acting Cabotegravir + Rilpivirine for HIV (ATLAS-2M Trial)
Phase 3
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects receiving oral SOC treatment for HIV-1 must meet specific criteria related to treatment history and viral load
Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS-2M study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41
Awards & highlights
ATLAS-2M Trial Summary
This trial is designed to compare the antiviral activity and safety of two regimens of an injectable combination of cabotegravir and rilpivirine given every 8 weeks or every 4 weeks, in adults living with HIV who are currently on a stable antiretroviral regimen.
Who is the study for?
Adults with HIV-1 who have maintained a viral load under 50 copies/mL and been on stable antiretroviral therapy for at least 6 months. Participants must understand the study commitments and be likely to complete them, not be pregnant or breastfeeding, and use effective contraception if of reproductive potential. Those with certain health conditions or taking specific medications are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of long-acting injections of Cabotegravir plus Rilpivirine given every two months compared to every month in controlling HIV-1. It includes adults previously treated with standard care or those already receiving these drugs monthly, assessing safety over a year.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medication components, injection site reactions such as pain or swelling, liver problems indicated by blood tests, potential interactions with other drugs leading to heart issues (like abnormal rhythms), and general symptoms like fatigue.
ATLAS-2M Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on standard HIV-1 treatment and meet specific criteria for treatment history and viral load.
Select...
I have been on the CAB LA + RPV LA treatment for at least 152 weeks as part of the ATLAS-2M study.
Select...
I am 18 years old or older.
Select...
I am able to understand and sign the consent form.
ATLAS-2M Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48
Secondary outcome measures
AUC for RPV LA
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48
Absolute Values for HIV-1 RNA at Week 48
+42 moreOther outcome measures
Number of Participants With Different Demographic Parameters for Inter-participant Variability
Number of Participants With Different Demographic Parameters for Intra-participant Variability
Side effects data
From 2023 Phase 3 trial • 687 Patients • NCT0454207059%
Injection site pain
18%
COVID-19
10%
Injection site nodule
10%
Injection site induration
9%
Headache
9%
Fatigue
9%
Injection site discomfort
8%
Injection site swelling
6%
Pyrexia
5%
Diarrhoea
5%
Nasopharyngitis
5%
Syphilis
1%
Angioedema
1%
Cholecystitis
1%
Urinary retention
1%
Herpes simplex meningoencephalitis
1%
Overdose
1%
Herpes simplex meningitis
1%
Bladder transitional cell carcinoma
1%
Back pain
1%
Acute myocardial infarction
1%
Alanine aminotransferase increased
1%
Substance abuse
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral lead-in Phase (OLI)
Direct to Injections (D2I)
Biktarvy (BIK)
ATLAS-2M Trial Design
4Treatment groups
Experimental Treatment
Group I: Subjects in group 2 receiving study treatment once in 8 weeksExperimental Treatment2 Interventions
Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to receive CAB LA plus RPV LA Q8W via IM route.
Group II: Subjects in group 2 receiving study treatment once in 4 weeksExperimental Treatment2 Interventions
Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to continue CAB LA plus RPV LA Q4W administration via IM route.
Group III: Subjects in group 1 receiving study treatment once in 8 weeksExperimental Treatment4 Interventions
Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q8W via IM route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Group IV: Subjects in group 1 receiving study treatment once in 4 weeksExperimental Treatment4 Interventions
Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q4W via intramuscular (IM) route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir Tablets
2020
Completed Phase 3
~710
Rilpivirine Tablets
2020
Completed Phase 3
~710
Cabotegravir Injectable Suspension
2021
Completed Phase 3
~120
Rilpivirine Injectable Suspension
2021
Completed Phase 3
~120
Find a Location
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
467,530 Total Patients Enrolled
Janssen Research and DevelopmentUNKNOWN
1 Previous Clinical Trials
118 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,142,881 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need long-term blood thinners, with some exceptions.I am allergic to the study drug or similar medications.I don't have any health issues that would affect how my body handles the study medication.I am not pregnant, not breastfeeding, and meet the fertility criteria.I am not taking any medications known to cause heart rhythm problems.My kidney function is reduced, with a creatinine clearance rate below 50 mL/min.I have used etravirine (ETR) before.I am taking medication that is not allowed in the trial and cannot change it.I am on standard HIV-1 treatment and meet specific criteria for treatment history and viral load.I have chronic hepatitis C but no symptoms.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.I may have a severe infection but not bad skin cancer or very low immunity cells.I have a tattoo or skin condition on my buttocks that could affect skin reaction assessments.I haven't taken certain medications in the last 28 days.I am currently taking tipranavir/ritonavir or fosamprenavir/ritonavir.I have been on the CAB LA + RPV LA treatment for at least 152 weeks as part of the ATLAS-2M study.I do not have serious liver, pancreas, or heart conditions.I am 18 years old or older.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I am able to understand and sign the consent form.I have no other cancers except for certain allowed types.I have moderate to severe liver problems.I haven't had cancer in the last 5 years, except for skin cancer.My cancer has mutations that make it resistant to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects in group 1 receiving study treatment once in 4 weeks
- Group 2: Subjects in group 1 receiving study treatment once in 8 weeks
- Group 3: Subjects in group 2 receiving study treatment once in 4 weeks
- Group 4: Subjects in group 2 receiving study treatment once in 8 weeks
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are Cabotegravir Tablets typically indicated for?
"Cabotegravir Tablets can be used to treat patients with HIV who have negative test results, have failed to respond to other treatments, or have developed viral resistance."
Answered by AI
Are Cabotegravir Tablets a new medication?
"Currently, there are 21 clinical trials underway for Cabotegravir Tablets. Of these, 7 are in Phase 3. Most of the research is happening in Sao Paulo and New york, but there are 640 total research sites for Cabotegravir Tablets."
Answered by AI
How many individuals are being invited to participate in this research project?
"Currently, this particular study is not seeking any more patients. It was originally posted on October 27th, 2017 and updated on November 1st, 2022. However, there are 495 other clinical trials actively recruiting patients with hiv infections and 21 studies for Cabotegravir Tablets that are searching for participants."
Answered by AI
Are there any risks associated with Cabotegravir Tablets?
"Cabotegravir Tablets have undergone multiple rounds of safety testing and there is some data supporting its efficacy, so our team at Power rates its safety as a 3."
Answered by AI
Are they enrolling new participants for this research project at this time?
"The study referenced is not currently seeking patients for enrollment, as noted on clinicaltrials.gov. This research was first made public on October 27th, 2017 and was last updated on November 1st, 2022. There are 516 other active studies that are looking for volunteers."
Answered by AI
How many different facilities are coordinating this clinical trial?
"The search for participants is currently underway at 41 sites, which are based in locations including but not limited to Cincinnati, New york and Bakersfield. If you are considering enrolling in the trial, please note that it may be beneficial to select a location near to you to cut down on travel."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
New York
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
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